Tilashani Samarakoon Email & Phone Number

Western Province, Sri Lanka

Western Province, Sri Lanka

Western Province, Sri Lanka

Sri Lanka

Ansell Lanka, Biyagama

Key Responsibilities  Responsible for Quality Operations and Quality Engineering *Q Engineering -Ensure change control of products -Ensure validations are conducted according to standard & regulatory requirements-Operation Qualifications/Performance Qualifications/Installation Qualifications and software validations -Ensure shelf life study compliance and bioburden level for changes against standards & regulations. -Ensure Risk Management conducted for every change of process or product according to ISO14971.-FMEA/DURA/RM Plan and RM report -Established Quality Function Deployment-QFD , Control Plan & SPC system transfer -Experience in Quality 4.0 practical transition*Q Operations -Supplier Quality Management : Prepare supplier audit plan & conduct supplier audits, Coordinate with the supplier if there is any non conformity, Coordinate with supplier related to incoming inspection discrepancies -Coordinate Corrective & Preventive actions-CAPA with the cross functional team by identifying trigger points and ensure effectiveness of the actions. -Coordinate Value Stream Mapping (VSM) project -Overlook Final release & Quality Control activities including in-process testing, final release testing, taking decisions on sampling plan, provide approval for product final release (Tensile testing, Friction testing, Water leak testing, thickness, powder level) -Team handling: Final Release & Quality Control team, Process Assessment team *RA functions as mentioned in previous job role. Key Achievements -Established SharePoint DMS for document control and established trade secret policy for formulations-Established QFD for all Medical products-Headcount optimization through VSM project-Transfer EU Technical files from MDD to MDR-Established MDF for all products,for MDSAP compliance

Ansell Lanka-Biyagama

Key Responsibilities  Responsible for Quality Systems and Regulatory Affairs*QMS -Maintaining ISO9001, ISO13485, FDA QSR & GMP in surgical, industrial & single use glove manufacturing. -Ensure plant readiness for notified body audits, customer audits and the unannounced audits and coordinate audits. -Document & record control. -Responsible for team coordination of Internal audit team and maintain collaboration with other functional teams to support IQA team. -Conduct annual Training Need Analysis-TNA for all QA department and ensure train the team at the right time. -Organize Management Review Meeting & Publish minutes. -Prepare & publish Monthly Report and ensure whether Quality Objectives are meet & CAPAs were raised accordingly. *RA -Maintain Technical files for Europe and Japan. -Prepare Technical documents for USA, Canada, Korea and brazil. -Register product according to country specific requirements & regulations in all over the world where Ansell products are selling. -Product registration in local authority-NMRA -Legalize products in foreign ministry according to country requirement -Responsible for REACH & PROP65 compliance of Raw Material -Packaging & labeling control according to country requirement -Ensure all regulatory requirements are fulfilled with EN, ASTM, ISO,MDR.FDA510k and other critical standards and regulations.Key Achievements -Successfully transfer QMS from ISO9001:2008 to ISO 9001:2015, EN ISO 13485:2012 to EN ISO 13485:2016 -Obtained a GMP certificate from NMRA for the first time in Ansell Lanka -Established a procedure for product registration at NMRA -Established Skill matrix to QA Admin team for employee development

Ansell Lanka-Biyagama

Key Responsibilities - Conducting internal audits all over the plants according to ISO 9001- Conducting internal audits in healthcare Global business unit according to ISO 9001,ISO 13485, FDA QSR, KGMP and Brazil GMP- Prepare & Maintain EU Technical files for Medical device to comply with MDDKey Achievements- Established Technical files for new products. - Established procedure for Regulatory Affairs.

Colombo, Western, Sri Lanka

-Maintaining ISO 9001:2008, ISO 22000:2005, HACCP and GMP and problem solving by using QM Tools-Ensure customer satisfaction by using cost effective methodologies.-Handling of customer complain & make corrective & preventive actions by using suitable problem solving tool. -Prepare Monthly QA summary reports.-Handle company safety & environmental compliances withing the department. -Ensure GMP practices withing the company. -Handling & testing of incoming material. Key Achievements-Successfully implemented the complaint investigation procedure & CAPA procedure.

Postgraduate Diploma, Manufacturing Management

This program was supported to improve theoretical knowledge in manufacturing. Below areas were covered during the program, -Industrial.

Master Of Business Administration - Mba, Business Administration And Management, General, Mba

By Following this, gain knowledge in below areas. -Accounting for Decision Makers -People and Organizations -Marketing -Strategic.

Bachelor Of Science (Bsc Hons-Encm), Department Of Zoology And Environmental Management, Faculty Of Science, University Of Kelaniya, Bsc(Hons)-Second Upper

Subjects learnt & demonstrate: -Chemistry : Physical Chemistry, Analytical Chemistry, Inorganic Chemistry, Organic Chemistry, General.

Diploma In Quality Management, Quality Management Systems, Diploma

By following this Diploma course gain knowledge on below areas, - Basic concept of Quality & standardization - Human Resource Management.

Diploma In Hrm, Human Resources Management And Services, Diploma

By following this Diploma Course enhance my knowledge in below areas. -What is Human Resources Management(HRM) -Human Resources Planning.

Diploma In Information Technology And E - Commerce, Information Technology And E - Commerce, Diploma

Higher School Education In Science Stream, Biology, Physics, Chemistry And All Subjects Related To Primary Education